Polypill strategy for the evidence-based management of heart failure with reduced ejection fraction in an underserved patient population

项目摘要/摘要 心力衰竭在美国构成了一个重大的公共卫生挑战，尤其是心力衰竭的患病率越来越高 在非白人个人和低社会经济地位(SES)个人中。数量不断增加的 已有证据表明，药物可以改善射血分数降低的心力衰竭患者的存活率。 (HFrEF)。指南指导的药物治疗(GDMT)清单包括β-受体阻滞剂、血管紧张素 转换酶抑制剂，血管紧张素受体阻滞剂，血管紧张素受体-奈普利辛抑制剂，以及 盐皮质激素受体拮抗剂。当联合使用时，这些药物可减少各种原因 死亡率为50%。尽管如此，只有不到25%的符合条件的患者接受了3种或3种以上的此类药物治疗 任何剂量，在低SES人群中利用率特别低。 多效药是指在单一药丸中固定剂量的药物组合，旨在减少药片负担和 提高遵从性。Polypill策略提供了一种用多种药物治疗的方法 在疾病的早期阶段方便地启动，随着时间的推移增加了总体治疗收益。 这在患者由于高昂的成本、频繁的 实验室检测，并需要多次随访。 我们提出了一项单中心、务实的试验，该试验以息肉为基础的策略治疗HFrEF的低... 收入，种族多元化的人口。我们将招募175名有左心室射血分数的成年人 [LVEF]&lt；40%)在Parkland医院接受治疗，但没有达到指南指导的最佳目标剂量 德克萨斯州达拉斯一家大型县医院的医疗治疗。参与者将被随机接受一种止痛药 或者照常照看。这项研究的主要终点是LVEF的变化，关键的次要结果将是 循环NT-ProBNP水平、生活质量、6分钟步行距离和对 指南指导12个月的内科治疗。我们假设使用一种基于多药的策略在 HFrEF将是可行的，并导致改善左心室收缩功能，NT-proBNP水平，生活质量， 与常规护理相比，坚持目标剂量指南指导药物治疗。

Project Summary/Abstract Heart failure poses a major public health challenge in the United States, with growing prevalence particularly among non-white individuals and individuals of low socioeconomic status (SES). An expanding number of medications have been shown to improve survival in patients with heart failure with reduced ejection fraction (HFrEF). The list of guideline-directed medical therapies (GDMT) includes beta-blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, and mineralocorticoid receptor antagonists. When used in combination, these medications reduce all-cause mortality by > 50%. Nonetheless, fewer than 25% of eligible patients receive 3 or more of these medications, at any dose, with particularly low rates of utilization among low SES individuals. The polypill refers to a fixed-dose combination of medications in a single pill, aimed at reducing pill burden and improving adherence. The polypill strategy offers a means by which therapy with multiple medications can be conveniently initiated at an early stage of disease, increasing the overall therapeutic benefit accrued over time. This is particularly relevant in settings where patients experience barriers to care due to high costs, frequent lab tests, and need for multiple follow up visits. We propose a single-center, pragmatic trial of a polypill-based strategy for the treatment of HFrEF in a low- income, racially-diverse population. We will enroll 175 adults with HFrEF (left ventricular ejection fraction [LVEF] < 40%) receiving care at Parkland Hospital who are not on optimal, target dose of guideline-directed medical therapy at a large county hospital in Dallas, TX. Participants will be randomized to receiving a polypill or usual care. The primary endpoint of the study is the change in LVEF, and the key secondary outcome will be change in circulating NT-proBNP levels, quality-of-life, six minute walk distance, and the adherence to guideline directed medical therapy at 12 months. We hypothesize that use of a polypill-based strategy in HFrEF will be feasible and lead to improved left ventricular systolic function, NT-proBNP levels, quality of life, and adherence to target dose guideline directed medical therapy compared with usual care.